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Research
Abstract reducing low back pain, the type of outcome measurement has
varied from study to study. To establish a standard instrument for
Objective To evaluate the effectiveness of acupressure in terms comparisons across studies, a standardised “core” set of
of disability, pain scores, and functional status. questions and questionnaires (referred to here as standard
Design Randomised controlled trial. outcome measures) has been proposed by an international pro-
Setting Orthopaedic clinic in Kaohsiung, Taiwan. gramme on primary care management of low back pain since
Participants 129 patients with chronic low back pain. 1998.8
Intervention Acupressure or physical therapy for one month. We aimed to do a randomised controlled trial using validated
Main outcome measures Self administered Chinese versions of Chinese versions of the standard outcome measures to compare
standard outcome measures for low back pain (primary the efficacy of acupressure with that of physical therapy in allevi-
outcome: Roland and Morris disability questionnaire) at ating low back pain and to provide a base for comparison across
baseline, after treatment, and at six month follow-up. international studies.
Results The mean total Roland and Morris disability
questionnaire score after treatment was significantly lower in
the acupressure group than in the physical therapy group Methods
regardless of the difference in absolute score ( − 3.8, 95% Study participants
confidence interval − 5.7 to − 1.9) or mean change from the The study took place between 8 January and 12 May 2004, with
baseline ( − 4.64, − 6.39 to − 2.89). Acupressure conferred an follow-up until 12 November 2004. We selected 188 participants
89% (95% confidence interval 61% to 97%) reduction in from among the outpatients of a specialist orthopaedic clinic in
significant disability compared with physical therapy. The Kaoshiung, Taiwan, which offered standardised physical therapy.
improvement in disability score in the acupressure group Patients were eligible if they were aged 18 years and older; they
compared with the physical group remained at six month had had chronic low back pain for more than four months, as
follow-up. Statistically significant differences also occurred diagnosed by a senior orthopaedic specialist; their chronic low
between the two groups for all six domains of the core back pain was not caused by systemic or organic diseases,
outcome, pain visual scale, and modified Oswestry disability cancers, or psychiatric diseases; they were not pregnant; they had
questionnaire after treatment and at six month follow-up. no acute severe pains needing immediate treatment or surgery;
Conclusions Acupressure was effective in reducing low back and they had no contraindication to acupressure (that is, no
pain in terms of disability, pain scores, and functional status. open wound). All participants gave written informed consent.
The benefit was sustained for six months.
Sample size determination
We did a pilot trial before the main study to obtain score means
Introduction
and standard deviations with the Roland and Morris disability
Low back pain is a common health problem worldwide. In addi- questionnaire, modified Oswestry disability questionnaire, and
tion to conventional physical therapy, acupuncture—classified in visual analogue scale for estimating sample sizes. We took the
group 1 of the complementary and alternative therapies (profes- Roland and Morris disability questionnaire as the primary
sionally organised alternative therapies)1—has been shown to be outcome. To detect the mean difference in score between the two
effective in alleviating various types of pain.2 Its efficacy for low groups (the mean scores in the pilot study were 28.4 (SD 16.9)
back pain remains elusive, however.3 Acupressure, another com- for the acupressure group and 48.0 (SD 22.9) for the physical
plementary and alternative therapy, has had increasing attention, therapy group), with a significance level of 5% (two tailed) and
as it is manipulated with the fingers instead of needles on the statistical power of 80%, we needed 65 participants in each arm.
acupoints and has been used for relieving pain, illness, and inju-
ries in traditional Chinese medicine.4 Randomisation
The efficacy of acupressure in relieving pain associated with A research assistant independently randomised participants by
low back pain has been shown by a randomised controlled trial.5 using a predetermined random table, which was not decoded
However, the outcomes in that study were assessed by until the intervention was assigned. After exclusion of ineligible
description of pain character and failed to take into account patients, 129 (69%) patients aged between 18 and 81 met our eli-
functional status and disability as recommended by most low gibility and were randomly allocated to two arms: 64 patients in
back pain researchers.6 7 Although trials have investigated the the acupressure group and 65 patients in the physical therapy
efficacy of physical therapy, acupuncture, and acupressure in group.
Table 1 Baseline characteristics of participants by treatment group. Values Table 2 Roland and Morris disability questionnaire (RMDQ) scores
are numbers (percentages) unless stated otherwise pretreatment, post-treatment, and at six month follow-up
Acupressure Physical therapy Sums of RMDQ Physical
Variable (n=64) (n=65) scores/ordinal Acupressure therapy
Mean (SD) age (years) 50.2 (13.8) 52.6 (17.2) scorings (0-24) (n=64) (n=65) Comparison 1† Comparison 2‡
Male sex 21 (33) 17 (26) Pretreatment
Marital status: Mean (SD) total score 10.9 (6.2) 10.0 (5.3) — —
Single 10 (16) 11 (17) Degree of disability
(No):
Married 54 (84) 54 (83)
Minimal (0-12) 36 45 — —
Education:
Significant (13-24) 28 20
College and above 17 (27) 14 (21)
Post-treatment
Senior high school 20 (31) 16 (25)
Mean (SD) total score 5.4 (5.0) 9.2 (5.8) −3.8*** −4.64***
Junior high school or below 27 (42) 35 (54)
(−5.7 to −1.9) (−6.39 to −2.89)
Occupation:
Degree of disability
Household keeper 18 (28) 16 (25) (No):
Office worker 17 (27) 8 (12) Minimal (0-12) 56 46 OR=0.11**
—
Heaver labour 9 (14) 8 (12) Significant (13-24) 8 19 (0.03 to 0.39)
Other 20 (31) 33 (51) Six month follow-up
Median (range) time since onset of pain (years) 3.3 (0.2-33.3) 1.6 (0.2-34.3) Mean (SD) total score 2.2 (3.2) 6.7 (5.5) −4.5*** −5.36***
Median (range) length of latest pain period 14.5 (0.02-360) 12 (0.25-432) (−6.1 to −2.9) (−7.21 to −3.52)
(months) Degree of disability
(No):
Minimal (0-12) 63 57 OR=0.07*
were lower in the acupressure group than in the physical therapy (0.01 to 0.57)
—
Significant (13-24) 1 8
group. The differences between the two groups remained statis-
†Absolute difference between groups analysed by Wilcoxon rank sum test for total scores,
tically significant (P < 0.05) after adjustment for pretreatment 95% confidence interval calculated by non-parametric jack-knife method; odds ratio (OR)
score and other baseline characteristics. In terms of mean (95% confidence interval) of showing significant degree of disability for acupressure
compared with physical therapy, analysed by multiple logistic regression.
change from baseline, the benefit was also greater in the
‡Difference (95% confidence interval) in mean change in score from baseline.
acupressure group for all variables (comparison 2 in table 3). *P<0.05.
The statistically significant improvement remained or even **P<0.01.
***P<0.0001.
increased at the six month follow-up (table 3).
Completed questionnaires
and randomised (n=129)
Lost to follow-up after one month (n=2) Lost to follow-up after one month (n=6)
Lost to follow-up after six months (n=9) Lost to follow-up after six months (n=11)
Pain score assessment after one month (n=63) Pain score assessment after one month (n=59)
Pain score assessment after six months (n=55) Pain score assessment after six months (n=54)
Trial profile
Table 3 Mean (SD) core outcome measures pretreatment, post-treatment, and at six month follow-up
Pre-treatment Post-treatment Six month follow-up
Core outcome
measures and Physical Physical Physical
related indicators Acupressure therapy Acupressure therapy Acupressure therapy
(n=64) (n=65) (n=64) (n=65) Comparison 1† Comparison 2‡ (n=64) (n=65) Comparison 1† Comparison 2‡
Degree of “how
bothersome”:
Low back pain 2.97 (1.01) 2.78 (0.96) 2.11 (0.86) 2.57 −0.53*** −0.64*** 1.59 (0.73) 2.17 −0.62*** −0.76***
(0.83) (−0.80 to −0.28) (−0.97 to −0.32) (0.89) (−0.90 to −0.35) (−1.13 to −0.39)
Leg pain 2.78 (1.16) 2.74 (1.11) 1.94 (0.85) 2.52 −0.60*** −0.63** 1.48 (0.71) 2.15 −0.68*** −0.71**
(0.97) (−0.87 to −0.34) (−0.97 to −0.29) (0.97) (−0.96 to −0.41) (−1.10 to −0.32)
Pain interferes 2.78 (1.11) 2.45 (0.98) 2.05 (0.88) 2.38 −0.50** −0.67** 1.61 (0.75) 2.23 −0.70*** −0.96***
with normal work (1.01) (−0.78 to −0.21) (−1.02 to −0.33) (0.88) (−0.98 to −0.42) (−1.35 to −0.57)
Satisfaction of life 1.39 (0.68) 1.57 (0.66) 2.38 (1.27) 1.97 0.46* 0.58** 3.63 (1.16) 2.95 0.69** 0.85**
with symptoms (1.04) (0.05 to 0.86) (0.15 to 1.02) (1.24) (0.27 to 1.11) (0.38 to 1.32)
Days cut down on 5.0 (10.5) 3.4 (8.6) 1.6 (4.7) 4.0 (9.8) −3.16** −3.99** 0.4 (2.6) 2.6 (8.0) −2.48* −3.70*
doing things (−5.38 to −0.93) (−6.83 to −1.15) (−4.45 to −0.50) (−6.98 to −0.42)
Days off from 4.2 (9.5) 3.3 (8.6) 1.5 (5.4) 3.5 (9.3) −2.45* −2.87* 0.6 (3.8) 2.5 (8.0) −2.15* −2.79
work/school (−4.59 to −0.31) (−5.51 to −0.23) (−4.22 to −0.09) (−5.94 to −0.35)
Satisfaction with 2.06 (1.39) 2.13 (1.68) 4.12 (1.22) 3.06 1.25*** 1.68*** 4.39 (0.75) 3.15 1.39*** 1.83***
previous (1.38) (0.82 to 1.68) (1.17 to 2.20) (1.14) (1.02 to 1.76) (1.37 to 2.29)
treatment
Pain visual scale (0 58.8 (17.88) 57 (17.83) 30.6 (21.75) 48.0 −18.38*** −19.27*** 16.1 (17.4) 41.4 −25.92*** −27.12***
to 100) (23.4) (−25.60 to −11.17) (−27.04 to −11.5) (24.6) (−33.06 to −18.77) (−35.3 to −18.94)
Sleeping with low 2.17 (0.86) 2.03 (0.97) 1.44 (0.59) 1.85 −0.46*** −0.55** 1.16 (0.44) 1.72 −0.61*** −0.71***
back pain (0.85) (−0.69 to −0.24) (−0.84 to −0.26) (0.84) (−0.82 to −0.39) (−1.02 to −0.39)
†Absolute difference (95% confidence interval) between groups by analysis of covariance.
‡Difference (95% confidence interval) in mean change in core outcome measures from baseline.
*P<0.05.
**P<0.01.
***P<0.0001.
with low back pain, and we included it as a reference indicator; it Moderate (12-22) 22 33
Severe (23-32) 2 11
showed a significant difference between the two groups in abso-
Crippled (33-43) 0 3
lute change and mean change from baseline at the post-
Bed bound (≥44) 0 0
treatment and six month follow-up assessments.
†Absolute difference (95% confidence interval) between groups by analysis of covariance.
Limitations of the study ‡Difference (95% confidence interval) in mean change in core outcome measures from
baseline.
Three concerns about the study should be clarified. Firstly, the **P<0.01.
efficacy of acupressure in pain relief might be attributed to a psy- ***P<0.0001.